MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 9MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE ROD, FIXATION, INTRAMEDULLARY

Model Number 04.037.944S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 11/01/2018

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation. Device not implanted or explanted. (b)(4). Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that on (b)(6) 2018, during hip surgery, the sales consultant (sc) passed off the wrong degree of the trochanteric fixation nail advanced (tfna) to the field. The surgeon asked for a 125 but a 130 nail was passed by him. The blade would not enter into the head of the patient and began to run through possible scenarios. Sc checked the box in the trash and it was a 130 nail. The nail was removed, and the correct nail was passed to the field. There was a surgical delay of ten (10) minutes and then proceeded. This report is for one (1) 9mm/130 deg ti cann tfna 235mm/right-sterile. This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 9MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8121851
• MDR Text Key: 129024521
• Report Number: 2939274-2018-55218
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 04.037.944S
• Device Catalogue Number: 04.037.944S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 12/01/2018 Patient Sequence Number: 1